Cooled RFA vs Conventional RFA to Manage Chronic Facetogenic Low Back Pain

(Lumbar CvS Trial)

Recruiting at9 trial locations

Overseen by David Provenzano

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Avanos Medical

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing two methods of using heat to treat chronic lower back pain. It targets patients whose pain comes from specific joints in the lower back. The treatment works by blocking pain signals from certain nerves. For years, heat has been used for comfort and pain relief and is recommended as a first-line therapy in many clinical guidelines.

Research Team

David Provenzano

Principal Investigator

Pain Diagnostics and Interventional Care

Eligibility Criteria

Inclusion Criteria

You are experiencing moderate to severe pain, with a score of 6 or higher on a pain scale from 0 to 10.

You have chronic low back pain for at least 3 months that is caused by a specific condition in your lower back joints. You have tried different non-surgical treatments like exercise, pain relief medication, and activity modification but haven't gotten enough relief.

If you take certain types of pain medication, such as Neurontin or Cymbalta, you must have been taking the same amount for at least 6 weeks before the study. You cannot change your dosage during the study without permission from the study doctor.

Exclusion Criteria

Your body has physical differences that would make it difficult to follow the study's procedures.

You have a medical condition that weakens your immune system and it is not under control.

You have severe narrowing in your spine that is causing nerve-related pain or difficulty walking.

Treatment Details

Interventions

• COOLIEF* Cooled Radiofrequency Probe (Radiofrequency Ablation)
• Standard Radiofrequency Probe (Radiofrequency Ablation)

Participant Groups

Group I: Cooled Radiofrequency Experimental Treatment 1 Intervention

Cooled radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain

Group II: Conventional Radiofrequency Active Control 1 Intervention

Conventional radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain

Who Is Running the Clinical Trial?

Avanos Medical

Lead Sponsor

Trials

9

Recruited

1,900+